Tissue fastening devices and related insertion tools and methods

ABSTRACT

The invention in certain aspects relates to a one-piece coil-shaped surgical fastener for fastening tissue segments, especially suitable for fastening segments of the lower esophogeal sphincter and fundus in an endoscopic procedure for the treatment of GERD. The invention also relates to related methods and devices for insertion of such a fastener, especially along a juncture of the surfaces of such tissue segments.

DESCRIPTION OF THE INVENTION

1. Field of the Invention

The present invention relates to surgical fasteners and, particularly,to tissue fasteners. Still more particularly, the present inventionrelates to tissue fasteners especially for use in a GERD fundoplicationprocedure.

2. Background of the Invention

Gastroesophageal reflux occurs when stomach acid enters the esophagus.This reflux of acid into the esophagus occurs naturally in healthyindividuals, but also may become a pathological condition in others.Effects from gastroesophageal reflux range from mild to severe. Mildeffects include heartburn, a burning sensation experienced behind thebreastbone. More severe effects include a variety of complications, suchas esophageal erosion, esophageal ulcers, esophageal stricture, abnormalepithelium (e.g., Barrett's esophagus), and/or pulmonary aspiration.These various clinical conditions and changes in tissue structure thatresult from reflux of stomach acid into the esophagus are referred togenerally as Gastroesophageal Reflux Disease (GERD).

Many mechanisms contribute to prevent gastroesophageal reflux in healthyindividuals. One such mechanism is the functioning of the loweresophageal sphincter (LES). With reference to FIG. 1, the LES is a ringof smooth muscle and increased annular thickness existing inapproximately the last four centimeters of the esophagus. In its restingstate, the LES creates a region of high pressure (approximately 15-30 mmHg above intragastric pressure) at the opening of the esophagus into thestomach. This pressure essentially closes the esophagus so that contentsof the stomach cannot pass back into the esophagus. The LES opens inresponse to swallowing and peristaltic motion in the esophagus, allowingfood to pass into the stomach. After opening, however, a properlyfunctioning LES should return to the resting, or closed state. Transientrelaxations of the LES do occur in healthy individuals, typicallyresulting in occasional bouts of heartburn.

The physical interaction occurring between the gastric fundus and theesophagus also prevents gastroesophageal reflux. The gastric fundus is alobe of the stomach situated at the top of the stomach proximal to theesophagus. In healthy individuals, the fundus presses against theopening of the esophagus when the stomach is full of food and/or gas.This effectively closes off the esophageal opening to the stomach andhelps to prevent acid reflux back into the esophagus.

In individuals with GERD, the LES functions abnormally, either due to anincrease in transient LES relaxations, decrease in length of theesophagus, decreased muscle tone of the LES during resting, or aninability of the esophageal tissue to resist injury or repair itselfafter injury. These conditions often are exacerbated by overeating,intake of caffeine, chocolate or fatty foods, smoking, and/or hiatalhernia. Avoiding these exacerbating mechanisms helps curb the negativeside effects associated with GERD, but does not cure the diseasecompletely.

A surgical procedure, known generally as fundoplication, has beendeveloped to prevent acid reflux in patients whose normal LESfunctioning has been impaired, either as a result of GERD or otherwise.Fundoplication involves bringing the fundus into closer proximity to theesophagus to help close off the esophageal opening into the stomach. InNissen Fundoplication, a particular type of the fundoplicationprocedure, the fundus is pulled up and around the esophagus and thensutured to itself and the esophagus such that it completely encirclesthe esophagus. Traditionally, this procedure has been performed as anopen surgery, but has recently enjoyed success as a laparoscopicprocedure, as discussed in McKernan, J. B., Champion, J. K.,“Laparoscopic antireflex surgery,” American Surgeon, Vol. 61, pp.530-536, (1995).

As with any open surgery, complications can occur as a result ofinfection, blood loss or from the use of anesthesia. Further, therelatively large incisions necessary in the performance of open surgeryrequire extended recovery times for the incision to heal. Thoughlaparoscopic surgical procedures reduce these negative effects by usingrelatively small devices at a relatively small incision site in theabdominal wall, there still exists an increased risk of infection due tothe incision. The location of the incision in the abdominal wallpresents a risk of other negative effects, such as sepsis, which can becaused by leakage of septic fluid contained in the stomach.

Other surgical procedures specifically address the LES. These proceduresattempt to prevent reflux by thickening the LES region and reducing thediameter of the esophageal opening to the stomach, i.e., tighten the LESregion. However, existing procedures are lengthy and difficult toperform.

SUMMARY OF THE INVENTION

The present invention includes tissue fasteners and related methods foran endoluminal tissue fastening procedure, especially suitable for thetreatment of GERD. To attain the advantages and in accordance with thepurpose of the invention, as embodied and broadly described herein, theinvention includes a one-piece surgical fastener for fastening tissuesegments. The fastener includes a coil-shaped portion having a proximalend and a distal end, a sharp tip at the distal end of the coil-shapedportion, and a substantially straight portion extending along theproximal end of the coil-shaped portion and substantially perpendicularto an axis of the coil-shaped portion.

According to other aspects, the invention includes a device forfastening a first segment of lower esophogeal sphincter tissue to asecond segment of fundus tissue. The device includes a one-piece tissuefastener having a coil-shaped portion and an elongate body configuredfor insertion into the esophagus. The elongate body has a proximal endand a distal end portion, and a passageway extending from the proximalend to the distal end portion to allow the passage of the fastenerthrough the elongate body. The device also includes an element connectedto and pivoting from the distal end of the elongate body. The elementhas an extended position at an angle to an axis of the elongate body anda retracted position substantially along an axis of the elongate body tohold the first and second tissue segments between the element and thedistal end portion of the elongate body. The device further includes atissue fastener advancer located in the passageway for advancing thetissue fastener in the passageway to the distal end portion of theelongate body and into the first and second tissue segments.

According to still further aspects, the invention includes a device forinserting a coil-shaped tissue fastener into body tissue segments. Thedevice includes a housing having a proximal end, a distal end portion, abody portion extending therebetween, and a passageway extending from theproximal end through the body portion and terminating at the distal endportion allowing the passage of fasteners through the housing. Thedevice also includes an arm pivotally attached to the housing at thedistal end portion and configured to hold the tissue segments to befastened between the arm and the distal end portion of the housing. Thedevice further includes means for advancing the fastener through thepassageway and into the tissue segments held between the arm and thedistal end portion.

According to even further aspects, the invention includes a method offastening a first segment of lower esophageal sphincter tissue to asecond segment of fundus tissue. The method includes the steps ofholding a first surface of the first tissue segment to a second surfaceof the second tissue segment; and inserting a coil-shaped fastener alonga juncture of the first and second surfaces.

Additional objects and advantages of the invention will be set forth inpart in the description which follows, and in part will be obvious fromthe description, or may be learned by practice of the invention. Theobjects and advantages of the invention will be realized and attained bymeans of the elements and combinations particularly pointed out in theappended claims.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and explanatory onlyand are not restrictive of the invention, as claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate several embodiments of theinvention and together with the description, serve to explain theprinciples of the invention.

FIG. 1 is a cross-sectional view of the gastrointestinal tract from amid-point of the esophagus to a point near the beginning of theduodenum.

FIGS. 2 and 2(a) respectively are side and end views of a tissuefastener, according to an embodiment of the present invention.

FIG. 3 is a sectional side view of the fastener of FIG. 2 insertedconsecutively through tissue segments, according to an embodiment of thepresent invention.

FIG. 4 is a sectional side view of the fastener of FIG. 2 inserted alongthe juncture of tissue segments, according to an embodiment of thepresent invention.

FIG. 5 is a side sectional view of a tissue fastener insertion device,according to an embodiment of the present invention.

FIG. 6 is a cross-sectional view of the insertion device of FIG. 5 takenalong line A-A.

FIG. 7 is a side view of a portion of the insertion device of FIG. 5with a tissue fastener of FIG. 2.

FIG. 8 is a sectional side view of the tissue fastener insertion deviceof FIG. 5 inserting a fastener into tissue segments.

FIG. 9 is a cross-section view of the insertion device, fastener, andtissue segments shown in FIG. 8 taken along line C-C.

DESCRIPTION OF THE EMBODIMENTS

Reference will now be made in detail to the present embodiments theinvention, examples of which are illustrated in the accompanyingdrawings. Wherever possible, the same reference numbers will be usedthroughout the drawings to refer to the same or like parts.

A newly developed form of fundoplication, referred to as endoscopicfundoplication, is an endoluminal procedure in which the fundus wall isfolded back onto the esophagus wall. The tissue fold formed between theesophagus and the fundus then is secured. Endoscopic fundoplication isintended to be performed as an endoluminal procedure in which insertionof required medical instruments occurs through the esophagus. Such aprocedure has the benefits of being less invasive, quicker, and lessexpensive as compared to previous techniques.

The present invention is directed to fasteners and methods especiallysuitable to fasten tissue in an endoscopic fundoplication procedure.According to embodiments of the present invention, the tissue fasteneris in the form of a one-piece coil, and the insertion device is adaptedto receive and insert the one-piece coil fasteners. In embodiments ofthe invention, the insertion device is adapted to helically wind thecoil fastener through both the tissue layers and along an axissubstantially parallel to the contact surfaces of the tissue layers. Theinsertion device according to the present invention may be used inconnection with an endoscope for viewing the operation site, or othersuitable endoscopic devices.

FIGS. 2 and 2(a) show a fastener 10 according to an embodiment of thepresent invention. Fastener 10 is shown as a helical coil 12. Coil 12has a leading end 14, preferably terminating in a point 16 for piercingthe tissue segments to be joined and easing the introduction of fastener10 into the tissue segments to be joined. The other end of coil 12terminates in a portion 18 bent along the diameter of coil 12. Portion18 is substantially straight and extends along the end of coil 12 andsubstantially perpendicular to an axis of coil 12.

The size (including diameter and length), pitch, and composition of coil12 may vary according to the particular application of fastener 10,including, for example, the length and width of the tissue segments tobe fastened. Examples of coil dimensions include a diameter of about ⅛″to ¾″, and preferably about ⅜″ diameter, and a length of about 5 mm to12 mm, and preferably about 6 mm in diameter. Coil 12 may be constructedfrom any biocompatible material having sufficient properties, includingappropriate rigidity, to retain two segments of tissue together.Suitable biocompatible materials include stainless steel (316 SS),nitinol, titanium, shape memory polymers such as polynorbene,polyethylene, PLLA, PGA, polyurethane, and PTFE, ceramics, andcompositions of materials such as a metal and a polymer or a filledpolymer. In addition, coil 12 could be constructed from any suitablebioabsorbable materials. If coil 12 is made of a bioabsorbable material,coil 12 would fasten the tissue segments together for an amount of timesufficient for the segments to grow into one another.

Fastener 10 may be wound helically into the tissue layers to be joined.Fastener 10 may be wound consecutively through each tissue layer 100, asshown in FIG. 3. In a preferred arrangement, fastener 10 is woundsimultaneously through both tissue layers 100 along a juncture 150 oftissue layers 100, as shown in FIG. 4. In that case, fastener 10 extendsalong an axis substantially parallel to juncture 150. By inserting thefastener along the juncture of the tissue layers, the size of thefastener need not be dependent on the thickness of the tissue layers.Because the fastener does not have to pass through the thickness of thetissue layers but rather passes along the longitudinal axis of thejuncture of the tissue layers, fastener 10 does not have to be of lengthto pass from one tissue layer to the adjoining tissue layer. As aresult, the same fastener may be used on tissue layers of varyingthickness.

The fastener also provides numerous other benefits by running along thelength of the tissue juncture. As examples, the fastener provides arelatively close and tight retention of the tissue segments, and thefastener reduces the total number of fasteners needed for a procedure.More specifically, one fastener of length x may be used to secure alength x of fundus to the esophagus.

The present invention also provides a device for insertion of fastenersdescribed above. As will be described, the fastener insertion devicesaccording to embodiments of the invention can easily reach internal bodysites, including the esophagus and stomach, can be used with fastenersof varying length and size, and can be used with multiple fasteners atone time.

FIG. 5 shows an embodiment of a tissue fastener insertion device 20according to the present invention. Device 20 is used to insert one ormore fasteners 10 into tissue segments to be joined. Insertion device 20includes an elongate member 23 having a main body portion 24 and adistal end portion 21. Elongate member 23 has a sufficient length sothat member 23 extends from a proximal end (not shown) that remainsoutside of a patient during an endoluminal fundoplication procedure,through the esophagus, and to distal end portion 21 in a stomach of thepatient.

A jaw assembly 25 articulates relative to distal end portion 21 at pivot26. A pin may be inserted within holes of jaw assembly 25 and endportion 21 to attach assembly 25 to end portion 21 and allow relativepivotal movement. Other suitable means for connecting jaw assembly 25 toend portion and permitting relative pivotal movement may be used.

Jaw assembly 25 includes a rotatable grasper 27 that rotates relative toa stationary grasper 28 to grasp the gastroesophageal junction. Graspers27 and 28 may include teeth for effectively grasping the tissue. Theteeth may be blunt or sharp depending on the type of tissue beinggrasped and the needs of the physician operating device 20. It is to beunderstood that grasper 28 alternatively may be pivotal. In addition,rather than graspers 27 and 28 being integral with device 20, anendoscopic grasping tool may be inserted through a lumen of device 20 tothe operative site for grasping the gastroesophageal junction.

Jaw assembly 25 also includes a relatively large pivoting outer arm 22to fold the fundus of the stomach onto the esophagus and retain thefundus in that position while a fastener is being inserted into thetissue fold.

The mechanism for actuation of jaw assembly 25, including graspers 27,28and arm 22, may include any suitable mechanism known to those in the artof endoscopic medical devices. As examples only, actuation mechanismsthat incorporate cables, vacuum, hydraulics, linkages, and/or cams maybe used. Further examples of suitable actuation mechanisms forendoluminal procedures, and details of fastener insertion devices,include those shown and described in U.S. Pat. Nos. 6,113,609 and6,086,600, the entire disclosures of which are incorporated by referenceherein. In an alternate embodiment, the graspers are separate from theinsertion device and jaw assembly. The graspers may be any medicaldevice known in the art to grasp tissue including, but not limited to,graspers, forceps, and baskets. The device is delivered to the tissuethrough a channel of the insertion device or adjacent to the insertiondevice.

As best shown in FIG. 6, insertion device 20 further includes a firstpassageway 29 for accommodating one or more endoscopic devices desiredto be used in the procedure. Passageway 29 extends from a proximal endof device 20, through portion 24, and terminates at an opening 35 atdistal end portion 21. As an example, an endoscope 45 may be extendedthrough passageway 29 to provide vision within the stomach afterinsertion of device 20. A 6 mm. diameter articulating endoscope may beused, however the size and type of endoscope can be selected dependingon the particularities associated with the procedure being performed.

Insertion device 20 further includes a second passageway 32 for passageof one or more fasteners 10. Passageway 32 preferably extends from theproximal end of housing 23, through the body portion 24, and terminatesat an opening 36 near distal end portion 21. An elongate member, suchas, for example, a rod 30, may be inserted into passageway 32 foradvancing tissue fastener 10 through passageway 32 and into the tissuesegments to be joined. Rod 30 is adapted to receive one or morefasteners 10 housed in passageway 32 and to transmit torque to fasteners10 in order to advance fasteners 10 through passageway 32 and into thetissue segments.

Referring to FIGS. 6 and 7, rod 30 preferably has a slot 34 extendingradially along at least a portion of its distal end for receiving endportion 18 of fastener 10, which extends along the diameter of coil 12.The radial length of slot 34 may vary depending on the length of endportion 18 extending along the diameter coil 12. Preferably, slot 34extends across the diameter of rod 30, as shown in FIG. 6, to allow theuse of coils having end portions of varying length. The axial length ofslot 34 may vary depending on the size and number of fasteners to beadvanced. Slot 34 extends at least along the distal end portion of 34and may extend up to its entire length to allow the use of multiplefasteners. The coil may be held in place with the rod in any number ofmanners, including, but not limited to friction, interference fit fromthe combination of the channel, the rod, the slot and the coil,interlocking sections between the rod and coil such as a flat spot onthe coil, teeth created within the slot, a wedge shaped portion withinthe slot, magnets or adhesives. As well, the passageway of the insertiondevice may be independently designed to assist in holding the coils androd together by manners including but not limited to friction fit,surface roughening, rifling or coating so that the coil cannot easilyfall forward.

Rod 30 is rotated and advanced distally to advance fastener 10 intotissue segments. Rotation and distal advancement may be caused manuallyby twisting and pushing on a handle of rod 30 at its proximal end,outside of the patient. Alternatively, rotation and distal advancementmay be caused by actuation of any suitable actuation mechanism attachedto or integral with rod 30 at its proximal end, outside of the patient.The rod and coil may be advanced in any number of manners known in theart comprising any combination of manual, mechanical, or energy assistedmeans including, but not limited to, a rotary motor and worm screwarrangement, a hand trigger lever to advance and turn the rod, a plungertype arrangement including a tapped hole and worm screw, a screw driverarrangement or the like. When rod 30 is rotated, the engagement of slot34 with end portion 18 of coil 12 transmits torque from rod 30 to coil12, causing coil 12 to rotate. As coil 12 advances, it exits passageway32 and enters the tissue segments to be joined.

A plurality of fasteners can be stacked end to end in compartment orpassageway 32. Multiple fasteners may be stacked one upon the otherwithin the slot of the rod. Each fastener will release from the rod andinsertion device as its proximal end exits the passageway. The slot ofthe rod may promote holding the fasteners until insertion is complete bymeans including, but not limited to, wedges or teeth along the slot,interlocking sections between the slot and coil, a slot spreader locatedat the end of the insertion device to release the coil, and the like. Inone embodiment, the rod is withdrawn from the distal end of theinsertion device after fastener insertion to receive the next coil inline for advancement.

To perform an endoscopic fundoplication procedure according to anembodiment of the present invention, device 20 is inserted through theesophagus of a patient and into the stomach. Insertion of device 20continues until the distal end of device 20 reaches a point within thestomach below the fundus. Device 20 preferably is inserted with the sidecontaining graspers 27,28 and arm 22 facing toward the fundus. However,it is contemplated that after insertion, device 20 can be rotated aboutits longitudinal axis to the desired position. Endoscope 45 may beextended through passageway 29 in device 20 to provide vision within thestomach before, during, or after insertion of device 20. Duringinsertion, graspers 27,28 and arm 22 remain in a closed position.

After inserting and positioning device 20 to the desired location belowthe fundus, arm 22 is opened and grasper 27 is pivoted to an openposition relative to grasper 28. Using a suitable visualizationtechnique, such as articulating endoscope 45, device 20 is then liftedupward toward the opening of the esophagus in the stomach. Next, grasper27 is closed relative to grasper 28 to grasp the gastroesophogealjunction. Arm 22 is then closed to engage the wall of the fundus andcause the fundus to fold against the side of the esophagus near itsopening into the stomach, as illustrated in FIG. 8.

After the fundus wall has been folded back onto the esophagus wall, itis secured into place with a fastener 10. To do so, rod 30 and afastener 10 are advanced through passageway 32 to opening 36 in device20. Once tip 16 of fastener 10 reaches the tissue segments to be joined,rod 30 is rotated and advanced distally so that fastener 10 is helicallywound into the tissue segments of the esophagus and stomach along thetissue juncture. In this way, fastener 10 is inserted parallel to theplane of the joined tissue segments 100.

Device 20 may include structure to stabilize the tissue segments to bejoined and aid in guidance of fastener 10 into the tissue segments. Inan embodiment shown in FIG. 9, an inner surface 50 of outer arm 22 andan opposing surface 60 of distal portion 21 are contoured to aid instabilizing the tissue segments and guiding fastener 10. The contouredsurfaces preferably comprise an inwardly rounded curve slightly largerthan that of coil 12 of fastener 10. While it should be recognized thateither outer arm 22 or opposing portion 21 could be contouredindependent of the other and still provide some guidance andstabilization, preferably both arm 22 and portion 21 are contoured toprovide greater guidance and stabilization.

The above-described procedure for securing a portion of the fundus wallonto the esophagus may be repeated around the circumference of theesophagus, if desired, to deliver a plurality of fasteners 10 about thatcircumference.

The insertion device and fundoplication procedure just described areexemplary of a device and procedure used with the fasteners and methodsto fasten tissue segments according to the present invention. It isdesirable that the fastening mechanisms and/or methods according to thepresent invention can be installed or performed relatively quickly in arelatively non-invasive manner, and can create a substantially uniformfold of tissue once installed. Although the fasteners and methodsaccording to the present invention are especially suitable for use in anendoscopic fundoplication procedure, those in the medical arts willunderstand that the fasteners and methods may be suitable for otherendoscopic and nonendoscopic surgical applications requiring thefastening of tissue segments.

Other embodiments of the invention will be apparent to those skilled inthe art from consideration of the specification and practice of theinvention disclosed herein. It is intended that the specification andexamples be considered as exemplary only, with a true scope and spiritof the invention being indicated by the following claims.

1-34. (canceled)
 35. A method of fastening a first segment of loweresophageal sphincter tissue to a second segment of fundus tissue,comprising: holding a first surface of the first tissue segment to asecond surface of the second tissue segment; and inserting a coil-shapedfastener along a juncture of the first and second surfaces.
 36. Themethod of claim 35, further comprising inserting into the esophagus andstomach a device for inserting the coil-shaped fastener.
 37. The methodof claim 36, wherein the device includes: an elongate body having aproximal end, a distal end portion, and a passageway extending from theproximal end to the distal end portion; an element connected to andpivoting from the distal end of the elongate body; and a tissue fasteneradvancer located in the passageway.
 38. The method of claim 37, whereinholding includes positioning the element substantially along an axis ofthe elongate body to hold the first and second tissue segments betweenthe element and the distal end portion of the elongate body.
 39. Themethod of claim 37, wherein inserting includes actuating the tissuefastener advancer to advance the tissue fastener in the passageway tothe distal end portion of the elongate body and into the first andsecond tissue segments.
 40. The method of claim 39, wherein actuatingthe tissue fastener advancer includes rotating and axially advancing thetissue fastener advancer.
 41. The method of claim 37, wherein thecoil-shaped fastener has a substantially straight portion extendingalong a proximal end, and the tissue fastener advancer includes a slotengaging the substantially straight portion during the inserting step.42. The method of claim 37, wherein the coil-shaped fastener has aproximal end, a distal end, and a sharp tip at the distal end.
 42. Themethod of claim 41, wherein the coil-shaped fastener has a substantiallystraight portion extending along the proximal end.
 43. The method ofclaim 42, wherein the substantially straight portion extends in adirection substantially perpendicular to a longitudinal axis of thecoil-shaped fastener.
 44. The method of claim 41, wherein at least aportion of the coil-shaped fastener tapers from the proximal end to thedistal end.
 45. The method of claim 35, wherein inserting includesinserting a plurality of coil-shaped fasteners.
 46. The method of claim35, further comprising grasping the gastroesophogeal junction prior tothe holding step.
 47. The method of claim 46, wherein grasping includesactuating a pair of jaws to grasp the gastroesophogeal junction.
 48. Amethod of fastening a first tissue segment to a second tissue segment,comprising: providing a device having an elongate body and an armrotatably connected to a distal end portion of the elongated body, theelongate body defining a passageway extending from a proximal end to thedistal end portion; rotating the arm relative to the elongate body so asto hold the first and second tissue segments between the arm and theelongate body; and advancing a coil-shaped fastener through thepassageway to insert the fastener along a juncture of the first andsecond tissue segments.
 49. The method of claim 48, wherein thecoil-shaped fastener has a proximal end, a distal end, and a sharp tipat the distal end.
 50. The method of claim 49, wherein the coil-shapedfastener includes a substantially straight portion extending along theproximal end and substantially perpendicularly to a longitudinal axis ofthe coil-shaped fastener.
 51. The method of claim 49, wherein at least aportion of the coil-shaped fastener tapers from the proximal end to thedistal end.
 52. The method of claim 48, wherein advancing includesactuating a tissue fastener advancer located in the passageway toadvance the fastener out of the distal end portion of the elongate bodyand into the first and second tissue segments.
 53. The method of claim52, wherein actuating the tissue fastener advancer includes rotating andaxially advancing the tissue fastener advancer.
 54. The method of claim48, wherein the first tissue segment is an esophageal tissue segment andthe second tissue segment is a fundus tissue segment.